(64 days)
The Echocardiography System provides a digital image transport and archive solution for hospitals wishing to replace their current VCR-based system. Currently, a typical cardiac echo department operates by manually shuttling VCR tapes between echo machines and VCR players. The Echocardiography System provides a high-speed digital link between these nodes. It also supports digital archival of echo exams in order to eliminate the cost and inconvenience of permanent storage via VCR tapes.
A digital image capture, storage, and review system for echocardiography.
The Echocardiography System provides a digital image transport and archive solution for hospitals wishing to replace their current VCR-based system. Currently, a typical cardiac echo department operates by manually shuttling VCR tapes between echo machines and VCR players. The Echocardiography System provides a high-speed digital link between these nodes. It also supports digital archival of echo exams in order to eliminate the cost and inconvenience of permanent storage via VCR tapes.
Here's a breakdown of the acceptance criteria and study information for the Camtronics Echocardiography System (K992259), based on the provided document:
This 510(k) submission states that performance data and conclusions from clinical/non-clinical test data were "Not required for determination of substantial equivalence for this class of device." This means that a specific study to prove the device meets acceptance criteria, as a primary submission requirement, was not conducted or submitted. The FDA's determination of substantial equivalence was based on a comparison to a predicate device, not on specific performance testing against pre-defined acceptance criteria.
However, based on the principle of substantial equivalence, the implicit acceptance criteria for the Camtronics Echocardiography System are its ability to function comparably to its predicate device, the MPACS "EchoLINK" (K980060), for the intended use of digital image transport and archival in echocardiography.
Below is a table summarizing the implicit "acceptance criteria" (based on predicate device specifications) and the reported performance of the Camtronics device, as well as the information directly asked for regarding a study, even if it wasn't explicitly required for this submission.
Acceptance Criteria and Reported Device Performance
| Feature / Criterion (Implicitly based on Predicate) | Predicate Device (MPACS "EchoLINK" K980060) | Camtronics Echocardiography System (Reported Performance) |
|---|---|---|
| Image Acquisition Unit | ||
| Compression type and ratio | MPEG2 up to 55:1 | JPEG, up to 30:1 |
| Video source | S-Video or Composite, NTSC or PAL | RGB, YC, or composite input |
| Computer/operating system | Pentium II, 350 MH/Windows NT4.0 | Pentium II/Windows NT4.0 |
| User interface | Keypad and trackball | User multifunction remote control, and mini-remote |
| Review Station | ||
| Image storage media | Internal hard disk, removable 3.5" magneto-optical disk | Internal hard disk, CD-R |
| Display | 21" color monitor, 1024x768, 24 bit color depth | 17", 19", or 21" color monitors, up to 1024x1024 24 bit depth |
| Computer/operating system | Pentium II, 350 MHz/Windows NT4.0 | Pentium II, 400 MHz/windows NT 4.0 |
| User interface | Keyboard and mouse | Keyboard, mouse, and rotary playback control |
| Image Server | ||
| Media | 100 CD-R | CD-R, or DLT tape, or others as available |
| Storage capacity | 20 minutes per CD-R at 4Mb/s MPEG2 | up to 2 weeks of studies on-line, and approx 1 year near-line |
| Network Type | Fast Ethernet | Fast Ethernet |
| DICOM compliance | Yes | Yes |
Study Information (Based on K992259 Document)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The document explicitly states: "Performance data: Not required for determination of substantial equivalence for this class of device." Therefore, no specific test set was used for a performance study.
- Data Provenance: Not applicable. No test data was required or provided.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set was used, and thus no ground truth was established by experts for a performance study.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set was used.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done. This device is an image transport and archive system, not an AI-assisted diagnostic tool.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No standalone performance study was done.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. As no performance study was conducted, no ground truth was established.
-
The sample size for the training set:
- Not applicable. This device is an image management system and does not rely on machine learning or require a training set in the conventional sense.
-
How the ground truth for the training set was established:
- Not applicable. No training set was used.
Summary regarding performance studies for K992259:
The FDA determined that for the Camtronics Echocardiography System, "Performance data: Not required for determination of substantial equivalence for this class of device." The clearance was based on substantial equivalence to a legally marketed predicate device (MPACS "EchoLINK" K980060) due to comparable intended use and technological characteristics, features, specifications, materials, and modes of operation. No new safety or effectiveness issues were raised. Therefore, the information typically requested about a study to prove acceptance criteria, including test sets, ground truth, experts, and adjudication, is not applicable to this particular 510(k) submission.
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Image /page/0/Picture/1 description: The image shows the logo for Camtronics Medical Systems. The logo consists of a stylized "C" shape with three horizontal lines inside, followed by the text "Camtronics" in a bold, sans-serif font. Below "Camtronics" is the text "MEDICAL SYSTEMS" in a smaller font. The date "SEP 8 1999" is printed below the logo.
510(k) Summary
Date prepared: June 30, 1999 Name of contact person: Robert Kriedermann Device trade name: Echocardiography System Common name: Echocardiography System Classification name: Picture Archiving and Communications System Predicate substantially equivalent devices: K980060 MPACS, LLC "EchoLINK"
Device description and intended use: The Echocardiography System provides a digital image transport and archive solution for hospitals wishing to replace their current VCR-based system. Currently, a typical cardiac echo department operates by manually shuttling VCR tapes between echo machines and VCR players. The Echocardiography System provides a high-speed digital link between these nodes. It also supports digital archival of echo exams in order to eliminate the cost and inconvenience of permanent storage via VCR tapes.
Predicate device specifications comparison:
| Principal Device | Predicate DeviceMPACS "EchoLINK" K980060 | |
|---|---|---|
| CamtronicsEchocardiography System | ||
| Image Acquisition Unit | ||
| Compression type andratio | JPEG, up to 30:1 | MPEG2 up to 55:1 |
| Video source | RGB, YC, or composite input | S-Video or Composite, NTSC orPAL |
| Computer/operatingsystem | Pentium II/Windows NT4.0 | Pentium II, 350 MH/WindowsNT4.0 |
| User interface | User multifunction remotecontrol, and mini-remote | Keypad and trackball |
| Review Station | ||
| Image storage media | Internal hard disk, CD-R | Internal hard disk, removable 3.5"magneto-optical disk |
| Display | 17", 19", or 21" color monitors,up to 1024x1024 24 bit depth | 21" color monitor, 1024x768, 24bit color depth |
| Computer/operatingsystem | Pentium II, 400 MHz/windowsNT 4.0 | Pentium II, 350 MHz/WindowsNT4.0 |
| User interface | Keyboard, mouse, and rotaryplayback control | Keyboard and mouse |
| Image Server | ||
| Media | CD-R, or DLT tape, or othersas available | 100 CD-R |
| Storage capacity | up to 2 weeks of studies on-line, and approx 1 year near-line | 20 minutes per CD-R at 4Mb/sMPEG2 |
| Network | ||
| Type | Fast Ethernet | Fast Ethernet |
| DICOM | Yes | Yes |
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Page 2 Camtronics Echocardiography System 510(k) Summary June 30, 1999
Performance data: Not required for determination of substantial equivalence for this class of device.
Conclusions drawn from clinical and nonclinical test data: Not required for determination of substantial equivalence for this class of device.
Substantial equivalence summary: The Camtronics Echocardiography System is a comparable type and substantially equivalent to a legally marketed predicate device. The intended use of the Camtronics Echocardiography System is the same as that of the predicate device "EchoLINK" marketed by MPACS, LLC. No new safety or effectiveness issues are raised with the Camtronics Echocardiography System. The subject device has substantially equivalent technological characteristics, features, specifications, materials, modes of operation, and intended uses as a legally marketed predicate device.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
8 1999 SEP
Robert Kriedermann Regulatory Specialist Camtronics, Ltd. 900 Walnut Ridge Drive P.O. Box 950 Hartland, Wisconsin 53029 Re:
K992259 Camtronics Echocardiography System Dated: June 30, 1999 Received: July 6, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Kriedermann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/2/Picture/15 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle's head, represented by three curved lines.
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l Page of
K992259 510(k) NUMBER (IF KNOWN) : Echocardiography System DEVICE NAME :
INDICATIONS FOR USE:
A digital image capture, storage, and review system for echocardiography.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ﮨﮯ (Per 21 CFR 801.109) OR
Over-The-Counter-Use (Optional Format 1-2-96)
David A. Syzman
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K992259
Over-The-Counter-Use
(Optional Format 1-2-
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).